Consultant - Regulatory Specialist RRDM
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Consultant - Regulatory Specialist RRDM

GSK Pharmaceuticals ltd 

Job Title: Consultant - Regulatory Specialist RRDM

Experience: 0-1  years

Location: Bengaluru

Job Description:

  • 0-1 years of experience in delivering business operational support (in the pharmaceutical industry, life sciences research, or regulatory). Have worked on regulatory submission, have a fair knowledge on the CAPA and audit reports

  • Demonstrated ability to proactively manage workload, timelines, and identify priorities. Build relationships with relevant internal functions.

  • Proven ability to work on multiple projects simultaneously.

  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner

  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

  • Has worked successfully with a complex computer system

  • Interacts with customers to ensure compliance with regulatory records and data management requirements.

Key Responsibilities:-

  • Accurate completion of routine data maintenance tasks to the agreed schedule

  • Ensure own work is compliant with data standards and defined procedures

  • Ensure defined quality control procedures are followed

  • Capable of performing routine data extraction from RIMS to support KPI generation

  • Maintain knowledge of GSK standards and procedures associated with RIMS and contribute to the definition of new and revised procedures to improve quality and effectiveness

  • Indexing, abstracting, and quality assurance of US/UK submissions and associated correspondence into the established regulatory document management system(s).

  • Supporting Legal and Business Development project works for document discovery, in-licensing, and out-licensing initiatives.

  • Support customer requests, as needed, by conducting specific searches for proprietary regulatory information using on-line databases.

  • Working on special projects as required in response to internal and external customer requests.

  • Support for IT-related activities.

  • Knowledge in delivering business operational support (in the pharmaceutical industry, life sciences research, or regulatory). Have worked on regulatory submission, have a fair knowledge on the CAPA and audit reports

  • Demonstrated ability to proactively manage workload, timelines, and identify priorities. Build relationships with relevant internal functions.

  • Proven ability to work on multiple projects simultaneously.

  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner

  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.

  • Has worked successfully with a complex computer system.

 

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